Data Integrity Challenges in the Pharmaceutical Microbiology Laboratory
A key foundation to Good Manufacturing Practice, is the execution and routine review of a robust environmental monitoring program. This takes the form of collecting environmental samples from surfaces, personnel and the cleanroom air, whether that be active or passive...
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APAS PharmaQC Pilot Secondary Validation Study Results
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This study assessed the performance of the APAS Independence with PharmaQC analysis module to identify growth on TSA culture media. The study assessed the performance on 1,515 environmental monitoring plates collected at AstraZeneca’s manufacturing facility during routine production.
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